The present invention relates to implantable medical devices. More particularly, the present invention pertains to apparatus and methods for use in the communication of information to/from an implantable medical device, e.g., programming commands, diagnostic information, etc.
Communication systems employing radio frequency (RF) transmitters and receivers are common. One application of such communication systems is in the field of body implantable medical devices, such as pacemakers, defibrillators, neural stimulators, and the like. RF communication is used to establish xe2x80x9cdownlinkxe2x80x9d telemetry channels, in which operational data and commands are transmitted from an external programming unit transmitter to a receiver in an implanted medical device, and/or is used to establish xe2x80x9cuplinkxe2x80x9d telemetry channels, in which information is transmitted from the implanted medical device""s transmitter to a receiver in the external unit.
A specific example of a particular component of a telemetry system for implantable medical devices is the Medtronic Model 9790 programmer, commercially available from Medtronic, Inc., the assignee of the present invention. The Model 9790 programmer, with appropriate software modules, can be used to communicate (both uplink and downlink) with numerous body implanted devices manufactured by Medtronic, Inc.
Conventionally, as exemplified by the Model 9790 programmer in conjunction with a Medtronic implantable medical device (e.g., a pacemaker), an antenna in the form of a multiple turn wire coil is disposed within the hermetic enclosure of the implanted medical device. Downlink RF signals transmitted to the implanted device from an external unit induce a current in the coil antenna, and this current is amplified and applied to a receiver input for demodulation and extraction of the information content of the RF signal. Similarly, for uplink communication, electrical current applied directly to the implanted coil antenna, cause RF electromagnetic signals to be generated. Such signals can be received by a corresponding antenna associated with the external unit.
For various reasons, including the desire to minimize the necessary strength of both uplink and downlink telemetry signals in implantable medical device systems, the external unit, e.g., programmer, of an implantable medical device system typically includes a relatively small, hand-held programming head containing an external antenna, so that this programming head can be placed directly over the implant site of the implanted device. This minimizes the distance between the implanted antenna associated with the implanted device and the external antenna associated with the programmer. For example, the head is typically connected to a larger base unit of a programmer via a multiple conductor cable. The aforementioned Model 9790 is one example of an implantable device programmer having this configuration. The Model 9790 is described in further detail in U.S. Pat. No. 5,345,362 to Winkler et al., entitled xe2x80x9cPortable Computer Apparatus With Articulating Display Panel.xe2x80x9d Further, a programming head and cable for use with such an implanted device programmer is described in U.S. Pat. No. 5,527,348 to Winkler et al., entitled xe2x80x9cMagnetically Permeable E-Shield And A Method Of Connection Thereto.xe2x80x9d
Various communication systems provide the necessary uplink and downlink communication channels between an external unit, e.g., programmer and the implanted medical device. However, some communication systems do not require the use of a hand-held programming head containing the external antenna. For example, such a communication system is described in U.S. Pat. No. 5,683,432 to Goedeke et al., entitled, xe2x80x9cAdaptive, Performance-Optimizing Communication System For Communicating With An Implanted Medical Device.xe2x80x9d
As the complexity of implantable medical devices increases over time, communication systems for enabling such implantable medical devices to communicate with external communication devices, e.g., programmers, has become more important. For example, it is desirable for a physician to non-invasively exercise some amount of control over the implanted medical device, e.g., to turn the device on or off after implantation, to adjust various parameters of the implantable medical device after implantation, etc.
Further, as implantable medical devices include more advanced features, it is typically necessary to convey correspondingly more information to the implantable medical device relating to the selection and control of such advanced features. For example, not only is a pacemaker selectively operable in various pacing modes, it is desirable that the physician be able to non-invasively select a mode of operation. Further, for example, if a pacemaker is capable of pacing at various rates or of delivering stimulating pulses of varying energy levels, it is desirable that the physician be able to select, on a patient-by-patient basis, appropriate values for such variable operational parameters. Various types of information are conveyed to implanted medical devices by telemetry systems. For example, information conveyed to pacemakers may include, but is clearly not limited to, pacing modes, multiple rate response settings, electrode polarity, maximum and minimum pacing rates, output energy such as output pulse width and/or output current, sense amplifier sensitivity, refractory periods, and calibration information.
Not only has the complexity of implantable medical devices led to the need to convey correspondingly more information to the implantable medical device, but it has also become desirable to enable the implanted medical device to communicate a large amount of information outside of the patient to an external communication device, e.g., programmer. For example, for diagnostic purposes, it is desirable for the implanted device to be able to provide information regarding its operational status to the physician. Further, various implantable medical devices are available which transmit information to an external communication device such as digitized physiological parameter signals, e.g., ECG, for display, storage, and/or analysis by the external communication unit. Generally, such information conveyed from the implanted medical device includes any type of diagnostic information and/or information relating to the physiological parameters of the patient in which the device is implanted.
Substantial technological improvements in the field of electronics over the past years has enabled computer equipment manufacturers to provide powerful, fully-featured computers that are compact and portable. Such computers have proven to be extremely popular and a wide variety of such computers are known and commercially available. A portable computer apparatus typically has at least a subset of the following components: a housing for containing the computer circuitry and other electronic components; a power source (e.g., a battery or a cable for connecting the apparatus to a source of power); a user input apparatus (e.g., an alphanumeric keyboard or a mouse); and an output means (e.g., a text and/or graphic display and/or a printer) for communicating information to the user. In addition, portable computer equipment will frequently be equipped with data storage devices, such as a floppy disk drive or a hard disk drive.
Conventional programmers have generally been xe2x80x9cstandalonexe2x80x9d devices and portable like that of portable computer apparatus as described above. For example, several available programmers include the Medtronic Model 9710 for which some further detail is described in U.S. Pat. No. 5,168,871 to Grevious, entitled xe2x80x9cMethod And Apparatus For Processing Quasi-Transient Telemetry Signals In Noisy Environmentsxe2x80x9d; Medtronic Model No. 9760 for which some further detail is described in U.S. Registration No. H1347 to Greeninger et al., entitled xe2x80x9cAudio Feedback For Implantable Medical Device Instruments;xe2x80x9d and Medtronic Model No. 9790 for which some further detail is described in U.S. Pat. No. 5,372,607 to Stone et al., entitled, xe2x80x9cMethod And Apparatus For Monitoring Pacemaker Intervals.xe2x80x9d Generally, such standalone devices are portable, as described above, completely self-contained devices that require the use of paper, cable connections, diskettes, or an infrared (IR) link to generate archival data.
Such conventional standalone programming apparatus have some shortcomings. For example, such standalone devices are generally time consuming to design and develop. Further, from a computer hardware perspective, such programming apparatus must continually be updated and upgraded to keep up with current hardware technology improvements, e.g., new processors, electrical circuitry, etc. As such, these programmers are generally relatively expensive.
In addition, conventional programming apparatus generally require that an extensive amount of diagnostic data be generated which is reviewed and integrated into a patient""s file. However, such data is generally required to be manually entered by either or all of the following methods including handwritten entry, keyboard entry, and printing of forms and then assembly of them into the patient""s file. This may lead to errors during the transfer of such data and limit the amount of data saved because of time constraints.
Table 1 below lists U.S. Patents relating to various components of implantable medical device communication systems.
All references listed in Table 1, and elsewhere herein, are incorporated by reference in their respective entireties. As those of ordinary skill in the art will appreciate readily upon reading the Summary of the Invention, Detailed Description of the Embodiments, and claims set forth below, at least some of the apparatus and methods disclosed in the references of Table 1 and elsewhere herein may be modified advantageously by using the teachings of the present invention. However, the listing of any such references in Table 1, or elsewhere herein, is by no means an indication that such references are prior art to the present invention.
The present invention has certain objects. That is, various embodiments of the present invention provide solutions to one or more problems existing in the prior art with respect to programming apparatus. One of such problems involves the use of standalone programmers. For example, with the use of standalone programmers, it is generally required to continually update hardware with the development of new technology. Further, design and development of standalone programmers is relatively expensive. Yet further, data generated by standalone programmers must generally be reviewed and integrated into a patient""s file. Due to the standalone nature of the programmers, it is sometimes necessary to manually enter such data into a patient""s file. Generally, such manual entering leads to undesirable errors in the patient""s file and limitation as to the amount of data saved.
In comparison to known programming apparatus, various embodiments of the present invention may provide one or more of the following advantages. For example, expensive hardware upgrading is reduced. Further, data generated by an implantable medical device may be integrated more readily and more comprehensively into a patient""s file. As such, errors due to manual entry may be eliminated. Further, for example, the use of an already existing infrastructure into which a programming apparatus according to the present invention is integrated, allows the programming apparatus to xe2x80x9cpiggybackxe2x80x9d on the natural progression of the infrastructure, e.g., hospital/clinic capital upgrades. Such a piggyback arrangement would reduce the need to continually upgrade operating systems, print options, database management, and connectivity requirements provided by the existing infrastructure. Further, it would reduce capital investment required by entities (e.g., hospitals, clinics, etc.) due to the already existing infrastructure to facilitate communication with the implantable medical device.
Some embodiments of the present invention include one or more of the following features: a module interface apparatus for facilitating communication between an implantable medical device and a medical information management system (e.g., a currently existing infrastructure of a medical facility computer communication network); a module interface apparatus including at least one of an interface receiver and an interface transmitter coupled to an interface antenna to communicate with at least one of a device transmitter and a device receiver of an implantable medical device; a module interface apparatus that includes interface circuitry operable to adapt data received from the medical information management system for provision to the interface transmitter to communicate such information to the implantable medical device; a module interface apparatus that includes interface circuitry to adapt data received from the interface receiver to communicate such information to a medical information management system; an interface module that includes a module housing which encloses at least one of an interface receiver and an interface transmitter wherein a programming head contains an interface antenna and a cable electrically connects the programming head to the interface module; an interface module that includes a module housing, wherein at least one of the interface receiver and interface transmitter are enclosed within the module housing and further wherein the interface antenna is external to the module housing; an interface module that includes processing circuitry to receive and process information signals from an interface receiver received from a implantable medical device; a plurality of interface modules, wherein each interface module is operable for use in communication of information between an external device corresponding to the interface module and a medical information management system; a medical information management system that includes a battery operable processing unit; a medical information management system that includes a computer network; programming commands provided to the interface module from a medical information management system; diagnostic and/or physiological parameter data provided from an interface module to a medical information management system; a programming method wherein data representing programming commands is received at an interface module, the data is adapted for transmission to the implantable medical device, and the adapted data is transmitted by an interface antenna to the implantable medical device; an implantable medical device uplink communication method wherein data is received from an interface module from a device transmitter of an implantable medical device by an interface antenna, the data received is adapted for provision to a medical information management system, and the adapted data is provided to the medical information management system.
The above summary of the present invention is not intended to describe each embodiment of every implementation of the present invention. Advantages, together with a more complete understanding of the invention, will become apparent and appreciated, by referring to the following detailed description and claims taken in conjunction with the accompanying drawings.